Posted on: 08/04/2026
Role Summary :
The Software Devl Analyst 2 (Python & R programmer) is a mid-senior individual contributor responsible for independently delivering clinical data programming, transformation, and review solutions in support of global clinical trials.
This role requires hands-on expertise in Python and R, strong understanding of clinical data standards, and the ability to work with minimal supervision while collaborating closely with Data Managers, Clinical Programmers, Statisticians, and Medical Reviewers throughout the study lifecycle.
- Independently develop and maintain Python and R programs for :
a. Clinical data cleaning
b. Data transformation
c. Data review and analysis
- Support downstream clinical data programming activities as defined in the Data Management Plan (DMP)
- Create and maintain data review listings, metrics, and utilities to support ongoing study conduct and database lock activities
- Perform detailed clinical data quality checks, trend analysis, and issue identification
- Support ongoing data review, reconciliation, and query resolution
- Ensure programming outputs meet accuracy, traceability, and audit readiness requirements
- Actively support interim and final database lock deliverables
- Apply and interpret CDISC standards (SDTM) in programming and data review
- Ensure compliance with ICH-GCP, 21 CFR Part 11, and internal SOPs
- Follow validated programming and documentation practices
- Contribute to inspection-ready deliverables
- Work closely with :
a. Data Managers
b. Clinical Programmers
c. Statisticians
d. Medical Reviewers
- Participate in cross-functional discussions related to data issues, timelines, and deliverables
- Provide technical input during study start-up, conduct, and close-out phases
- Develop reusable Python/R utilities and scripts to improve efficiency
- Contribute to process automation, standardization, and innovation initiatives
- Identify opportunities to reduce manual effort in data review and reporting
- Strong hands-on experience in Python and R
- Proficiency with :
a. Python : Pandas, NumPy
b. R for statistical analysis and data exploration
c. Strong SQL skills
- Proven experience working with clinical trial data
- Solid understanding of CDISC / SDTM standards
- Experience in regulated clinical data environments
- Clinical data systems (EDC / CDB / CDMS)
- Data review and reporting tools
- Version control systems (e.g., Git)
- Experience supporting data ingestion and transformation workflows
- Bachelor's or Master's degree in :
a. Computer Science
b. Statistics
c. Data Scienced
d. Life Sciences
e. Engineering (or equivalent practical experience)
- Ability to read and interpret SAS programs
- Exposure to Veeva, Oracle, Rave, or similar EDC platforms
- Experience with ETL processes
- Dashboarding / visualization exposure (Power BI, Tableau)
- Prior experience supporting global or complex clinical studies
- Works independently with minimal supervision
- Strong analytical and problem-solving skills
- High attention to detail and data quality
- Effective communication with cross-functional stakeholders
- Demonstrates ownership, accountability, and delivery focus
- Adaptable to changing study and project needs
- Operates as a fully productive individual contributor
- Owns assigned programming deliverables end-to-end
- May mentor junior team members (Grade 130) informally
- Does not have formal people-management responsibility
- Contributes to process improvements and standardization
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Posted in
Backend Development
Functional Area
Data Analysis / Business Analysis
Job Code
1626911